FDA Approves Rybrevant for NSCLC With EGFR Exon 19 Deletions or L858R Mutations

The FDA has approved amivantamab-vmjw (Rybrevant, Janssen Biotech) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

Efficacy was evaluated in MARIPOSA-2 (ClinicalTrials.gov. Identifier: NCT04988295), a multicenter, randomized,